Endovascular aneurysm devices, systems, and methods

ABSTRACT

Devices, systems, and methods for implanting prostheses in the body lumens rely on tacking or anchoring the prostheses with separately introduced fasteners. After initial placement, a fastener applier system is introduced within the expanded prostheses to deploy a plurality of fasteners to at least one prosthesis end. The fasteners are usually helical fasteners which are releasably restrained on the fastener driver, and are delivered by rotation of the fastener driver. The fasteners may be applied singly, typically in circumferentially spaced-apart patterns about the interior of at least one end of the prosthesis. A lumen extension or lumens may be coupled to the prosthesis to extend the reach of the prosthesis within the implantation site. Fasteners may also be applied to the lumen extensions.

RELATED APPLICATIONS

This application is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled“Devices, Systems, and Methods for Prosthesis Delivery andImplantation,” which is incorporated herein by reference. Thisapplication also is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 10/692,283, filed Oct. 23, 2003, and entitled“Prosthesis Delivery Systems and Methods,” which claims the benefit ofU.S. Provisional Patent Application Ser. No. 60/488,753, filed Jul. 21,2003, and entitled “Endoprosthesis Delivery Systems and Methods.” Thisapplication also is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 10/786,465, filed Feb. 25 2004, and entitled“Systems and Methods for Attaching a Prosthesis Within a Body Lumen orHollow Organ.” This application is also a continuation-in-part ofco-pending U.S. patent application Ser. No. 11/693,255, filed Jun. 24,2005, entitled “Multi-Lumen Prosthesis Systems and Methods,” which is adivision of U.S. patent application Ser. No. 10/693,255, filed 24 Oct.2003 (now U.S. Pat. No. 6,929,661), which claims the benefit of U.S.Provisional Patent Application Ser. No. 60/489,011, filed Jul. 21, 2003,and entitled “Bifurcated Prosthesis Systems and Methods.” Thisapplication also is a continuation-in-part of co-pending U.S. patentapplication Ser. No. 10/307,226, filed 29 Nov. 2002, and entitled“Intraluminal Prosthesis Attachment Systems and Methods.” Thisapplication is also a continuation-in-part of copending U.S. patentapplication Ser. No. 10/669,881, entitled “Catheter-Based FastenerImplantation Apparatus and Methods with Implantation Force Resolution.”This application is also a continuation-in-part of copending U.S. patentapplication Ser. No. 11/166,411, filed Jun. 24, 2005, entitled“Endovascular Aneurysm Repair System,” which is a division of U.S.patent application Ser. No. 10/271,334, filed 15 Oct. 2002 (now U.S.Pat. No. 6,960,217), which claims the benefit of U.S. Provisional PatentApplication Ser. No. 60/333,937, filed 28 Nov. 2001, and entitled“Endovascular Aneurysm Repair System.” Each of the precedingapplications is incorporated herein by reference.

FIELD OF THE INVENTION

The invention relates generally to devices, systems, and methods for thedelivery and implantation of a prosthesis to a targeted site within thebody, e.g., for the repair of diseased and/or damaged sections of ahollow body organ and/or blood vessel.

BACKGROUND OF THE INVENTION

The weakening of a vessel wall from damage or disease can lead to vesseldilatation and the formation of an aneurysm. Left untreated, an aneurysmcan grow in size and may eventually rupture.

For example, aneurysms of the aorta primarily occur in the abdominalregion, usually in the infrarenal area between the renal arteries andthe aortic bifurcation. Aneurysms can also occur in the thoracic regionbetween the aortic arch and renal arteries. The rupture of an aorticaneurysm results in massive hemorrhaging and has a high rate ofmortality.

Open surgical replacement of a diseased or damaged section of vessel caneliminate the risk of vessel rupture. In this procedure, the diseased ordamaged section of vessel is removed and a prosthesis, made either in astraight or bifurcated configuration, is installed and then permanentlyattached and sealed to the ends of the native vessel by suture. Theprosthesis for these procedures are usually unsupported woven tubes andare typically made from polyester, ePTFE or other suitable materials.The prosthesis are longitudinally unsupported so they can accommodatechanges in the morphology of the aneurysm and native vessel. However,these procedures require a large surgical incision and have a high rateof morbidity and mortality. In addition, many patients are unsuitablefor this type of major surgery due to other co-morbidities.

Endovascular aneurysm repair has been introduced to overcome theproblems associated with open surgical repair. The aneurysm is bridgedwith a vascular prosthesis, which is placed intraluminally. Typicallythese prostheses for aortic aneurysms are delivered collapsed on acatheter through the femoral artery. These prostheses are usuallydesigned with a fabric material attached to a metallic scaffolding(stent) structure, which expands or is expanded to contact the internaldiameter of the vessel. Unlike open surgical aneurysm repair,intraluminally deployed prostheses are not sutured to the native vessel,but rely on either barbs extending from the stent, which penetrate intothe native vessel during deployment, or the radial expansion force ofthe stent itself is utilized to hold the prosthesis in position. Theseprosthesis attachment means do not provide the same level of attachmentwhen compared to suture and can damage the native vessel upondeployment.

Accordingly, there is a need for improved prosthesis delivery devices,systems, and methods that deliver a prosthetic graft to a body lumen,the prosthesis being able to adapt to changes in aneurysm morphology andable to be deployed safely and without damage to the native vessel.

SUMMARY OF THE INVENTION

One aspect of the invention provides a system comprising a guidedefining an access path into a vessel or hollow body organ and afastener applier comprising a catheter sized and configured forintroduction along the access path to a site targeted for implantationof at least one fastener. The guide includes a distal region withterminus. The fastener applier includes an actuated member that isselectively operable to generate an implantation force to implant the atleast one fastener within tissue at the site. According to this aspectof the invention, the catheter includes indicia visible to a naked eyeto mark when the actuated member rests at a desired distance along theaccess path short of the terminus of the distal region and is thereforestill out of contact with tissue. The visible indicia makes it possiblefor the physician, without resort to fluoroscopic visualization or othervisualizations techniques that augment human sight, to always knowwhether the fastener is within or outside the guide.

This aspect of the invention also provides instructions for using theguide and fastener applier in which, as the actuated member is beingintroduced along the access path toward the terminus, the operator orphysician is instructed to view the indicia with a naked eye, to detectwhen the actuated member rests at a desired distance along the accesspath short of the terminus of the distal region.

Another aspect of the invention provides for a fastener applier anelectrically powered drive member coupled to the driven member and acontroller coupled to the drive motor. According to this aspect of theinvention, the controller includes a LOAD state. In the LOAD state, thecontroller operates in response to an input command for deliveringelectrical current to the drive member to drive the driven member in afirst direction to load a fastener onto the driven member. Thecontroller senses electrical current delivered to the drive member whileloading the fastener onto the driven member. The controller terminatesdelivery of electrical current to the driven member when a prescribedamount of current is delivered to the drive member, thereby terminatingthe LOAD state.

On one embodiment, the controller also includes an UNWIND state thatfollows the LOAD state. In the UNWIND state, which is operative aftertermination of the LOAD state, the controller delivers electricalcurrent to the drive member to drive the driven member in a seconddirection. The controller senses a period of operation of the drivenmember in the second direction which is sufficient to reduce torquewindup on the driven member created during the LOAD state. Thecontroller terminates delivery of electrical current to the drivenmember after the period of operation, thereby terminating the UNWINDstate. According to this aspect of the invention, the fastener applierenters a READY TO APPLY state with a minimum of torque windup associatedwith the driven element.

Another aspect of the invention provides a fluid seal assembly usable inassociation with, e.g., a catheter assembly including an operativeelement that, in use, is exposed to a body fluid, a control element, acontrol filament coupled at one end to the control element and to anopposite end to the operative element. In this arrangement, the sealassembly is positioned between the control element and the operativeelement, and the control filament passes through the seal assembly toprevent contact between the body fluid and the control element.

According to this aspect of the invention, the seal assembly comprises afirst seal component with at least one guide tube formed therein, and asecond seal component with at least one guide tube formed therein. Thesecond seal component registers with the first seal component with atleast one guide tube in the second component coaxially aligned with atleast one guide tube in the first component. A septum is sandwichedbetween the first and second seal components. The septum accommodatespassage of the control filament from one the coaxially aligned guidetubes, through the septum, to the other one of the coaxially alignedguide tubes, thereby providing a fluid seal for the control filamentthat prevents the control element from contacting body fluid to whichthe operative element is exposed during use.

Other features and advantages of the invention shall be apparent basedupon the accompanying description, drawings, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a view of the components of a system for repairing anendovascular aneurysm.

FIG. 2 is a view of the components of the system shown in FIG. 1consolidated for use in a multiple piece kit, along with instructionsfor their use.

FIG. 3A is a view of the main body of the endovascular graft that formsa part of the system shown in FIG. 1.

FIG. 3B is a view of a lumen extension of the endovascular graft thatforms a part of the system shown in FIG. 1.

FIG. 3C is an anatomic view of the main body and lumen extensions of thegraft assembly assembled within an abdominal aortic aneurysm.

FIG. 4A is a view of the delivery system for the main body of theendovascular graft, which forms a part of the system shown in FIG. 1.

FIGS. 4B and 4C are views of the top and bottom of the control handle ofthe main body delivery system shown in FIG. 4A.

FIG. 4D is a view of the distal end of the main body delivery systemshown in FIG. 4A, with parts broken away to show the attachment of themain body of the endovascular graft to the delivery system and therelease wire and jacket controls that are coupled to the handle toaffect a controlled stepwise release of the main body from the deliverysystem.

FIG. 4E is a view of the distal end of the main body delivery systemshowing the retracted and advanced positions of the slidable releasejacket.

FIG. 5A is a view of the handle of the main body delivery system shownin FIG. 4A, with portions broken away to show a hemostatic seal assemblywithin the housing.

FIGS. 5B and 5C are, respectively, exploded and assembled views of thehemostatic seal assembly shown in FIG. 5A.

FIG. 5D is an enlarged view of the hemostatic seal assembly within thehandle of the main body delivery system, showing the passage of therelease wires through the seal assembly between the control mechanismsand the distal end of the main body delivery system (as shown in FIG.4D).

FIG. 6A is a view of the delivery system for a lumen extension of theendovascular graft, which forms a part of the system shown in FIG. 1.

FIGS. 6B and 6C are views of the top and bottom of the control handle ofthe lumen extension delivery system shown in FIG. 6A.

FIG. 6D is a view of the distal end of the lumen extension deliverysystem shown in FIG. 6A, with parts broken away to show the attachmentof a lumen extension of the endovascular graft to the delivery systemand the release wire and jacket controls that are coupled to the handleto affect a controlled release of the lumen extension from the deliverysystem.

FIG. 7A is a view of the steerable endovascular guide and obturator thatform a part of the system shown in FIG. 1.

FIG. 7B is an enlarged view of the handle of the steerable endovascularguide shown in FIG. 7A.

FIG. 8A is a view of a endovascular fastener or staple that forms a partof the system shown in FIG. 1.

FIGS. 8B and 8C are views of a cassette to hold the a plurality ofendovascular fasteners, as shown in FIG. 8A, and to present thefasteners for loading in the staple applier, which also forms a part ofthe system shown in FIG. 1.

FIG. 9A is a view of a fastener applier for implanting a fastener asshown in FIG. 8A, which forms a part of the system shown in FIG. 1.

FIG. 9B is an enlarged view of the handle of the fastener applier shownin FIG. 9A.

FIG. 10A is a view showing the manipulation of the fastener appliershown in FIG. 9A in loading a fastener from the cassette shown in FIGS.8B and 8C.

FIGS. 10B and 10C are anatomic views showing the actuated element at thedistal end of the fastener applier being driven to implant a fastener ina graft and adjacent tissue, to secure the position of the graft.

FIG. 11A is a view showing a fastener applier of a type shown in FIG.9A, which includes indicia visable to a naked eye.

FIG. 11B is a view showing the fastener applier shown in FIG. 11A inassociation with a steerable endovascular guide of a type shown in FIG.7A, showing how the indicia, which is visible to a naked eye, marks whenthe actuated member rests at a desired distance within the guide shortof the terminus of the guide and therefore out of contact with tissue.

FIG. 11C shown the distal end of the guide when the indicia visible atthe proximal end of the guide marks when the actuated member rests at adesired distance within the guide short of the terminus of the guide andtherefore out of contact with tissue.

FIGS. 12A to 12P are anatomic views of manipulation of the components ofthe system shown in FIG. 1 in placing a prosthesis in an abdominalaortic aneurism, which manipulations can be incorporated within aninstruction for use associated with a kit like that shown in FIG. 2.

FIG. 13A is a schematic view of the motor control functions of arepresentative control circuit for the fastener applier shown in FIG.9A.

FIG. 13B is a schematic flow diagram of the operational states of thecontrol circuit shown in FIG. 13A.

DETAILED DESCRIPTION

This Specification discloses various catheter-based devices, systems,and methods for delivering and implanting radially expandable prosthesesin the body lumens. For example, the various aspects of the inventionhave application in procedures requiring the repair of diseased and/ordamaged sections of a hollow body organ and/or blood vessel. Thedevices, systems, and methods that embody features of the invention arealso adaptable for use with systems and surgical techniques that are notnecessarily catheter-based.

The devices, systems, and methods are particularly well suited fortreating aneurysms of the aorta that primarily occur in the abdominalregion, usually in the infrarenal area between the renal arteries andthe aortic bifurcation, as well as aneurysms that also occur in thethoracic region between the aortic arch and renal arteries. For thisreason, the devices, systems, and methods will be described in thiscontext. Still, it should be appreciated that the disclosed devices,systems, and methods are applicable for use in treating otherdysfunctions elsewhere in the body, which are not necessarilyaorta-related.

When referring to an endovascular graft or its components that areintended to be implanted in a vessel or body organ, the terms “proximal”and “distal” will be used to describe the relation or orientation of thegraft with respect to the heart after implantation. Therefore, the term“proximal” will be used to describe a relation or orientation of thegraft that, when implanted, is toward the heart, and the term “distal”will be used to describe a position or orientation of the graft that,when implanted, is away from the heart, i.e., toward the feet.

When referring to implantation apparatus or devices that are manipulatedby a physician or operator in order to implant the endovascular graft orits components, the terms “proximal” and “distal” will be used todescribe the relation or orientation of the apparatus or device withrespect to the operator as it is used. Therefore, the term “proximal”will be used to describe a relation or orientation of the apparatus ordevice that, when in use, is positioned toward to the operator (i.e., atthe handle end of the device), and the term “distal” will be used todescribe a position or orientation of the apparatus or device that, whenin use, is positioned away from the operator (i.e., at the other end ofa catheter or the like away from the handle).

I. System Overview

FIG. 1 shows a system 10 for repairing an endovascular aneurysm, whichis well suited for the repair of an abdominal aortic aneurysm (AAA). Thesystem 10 comprises three primary components 12, 14, and 16.

The first component 12 comprises an endovascular graft assembly. In use,the endovascular graft assembly 12 is placed within a vessel at the siteof the aneurysm. In the illustrated embodiment, the endovascular graftassembly 12 includes a main body 18 that is placed within the aortaadjacent the renal arteries (see FIG. 3C), and lumen extensions 20 and22 that extend into the contralateral and ipsilateral branches of theiliac artery, as FIG. 3C shows.

The second component 14 comprises an endovascular delivery system forintroducing and deploying in sequence the main body 18 and lumenextensions 20 and 22 of the endovascular graft assembly 12 using anendovascular approach. In the illustrated embodiment, in which theendovascular graft assembly 12 comprises three modular portions—the mainbody 18, the ipsilateral lumen extension 20, and the contralateral lumenextension 22—there are three corresponding endograft delivery components24, 26, and 28.

The third component 16 comprises an endovascular stapling system. Inuse, the endovascular stapling system 16 attaches one or more regions ofthe endovascular graft assembly to the vessel wall with one or moreendovascular staples. In the illustrated embodiment, the endovascularstapling system 16 comprises a steerable endovascular guide 30, anobturator 32, a cassette 34 holding a plurality of endovascular staples36, and an endovascular staple applier 38. In use, the steerableendovascular guide 30 establishes an endovascular path to the targetedsite where the endovascular graft assembly 12 has been partially orfully deployed. The steerable endovascular guide 30 is manipulated byflexure and rotation to successive sites where individual endovascularstaples 36 are to be implanted, to penetrate the endovascular graftassembly 12 and adjacent vessel wall. The endovascular staple applier38, carrying one or more endovascular staples 36, is guided by thesteerable endovascular guide 30 to the successive sites. Theendovascular staple applier 38 is actuated to implant individualendovascular staples 36 into selected region or regions of theendovascular graft assembly 12 and adjacent vessel wall, to attach theendovascular graft assembly 12 to the vessel wall.

II. The Kit

As FIG. 2 shows, the various tools and devices as just described,comprising the system 10, can be consolidated for use in a multiplepiece functional kit 40.

The kit 40 can take various forms. In the illustrated embodiment, thekit 40 comprises an assemblage of individual packages 42, 44, 46, 48,50, 52, 54, and 56, each comprising a sterile, wrapped, peel-openassembly. One or more the packages may include an interior tray made,e.g., from die cut cardboard, plastic sheet, or thermo-formed plasticmaterial, which hold the contents. The kit 40 also preferably includesinstructions or directions 58 for using the contents of the packages tocarry out a desired procedure. A desired procedure using the contents ofthe kit 40 shown in FIG. 2 will be described in greater detail later.

The instructions for use 58 can, of course vary. The instructions foruse 58 can be physically present in one or more of the packages, but canalso be supplied separately. The instructions for use 58 can be embodiedin separate instruction manuals, or in video or audio recordings. Theinstructions for use 58 can also be available through an internet webpage.

A. The Component Packages

The arrangement and contents of the packages can vary.

For example, as shown in FIG. 2, the kit 40 comprises eight packages 42,44, 46, 48, 50, 52, 54, and 56. Five of these packages 42, 44, 46, 48,and 50 provide the main components of the endovascular repair system 10as described. The remaining packages 52, 54, and 56 provide ancillarycomponents used in the deployment of the system 10, e.g., conventionalvascular access sheaths (in package 52); conventional 0.035 inch guidewires (in package 54); and bags containing heparinized saline forcatheter flushing and contrast for angiography (in package 56).

In package 42, the main body 18 of the endovascular graft assembly 12 ispreloaded into the main body endograft delivery components 24. Inpackage 44, the ipsilateral lumen extension 20 of the endovascular graftassembly 12 is preloaded into the ipsilateral extension endograftdelivery component 26. In package 46, the contralateral lumen extension22 of the endovascular graft assembly 12 is preloaded into thecontralateral extension endograft delivery component 28. Housed withinthe packages 42, 44, and 46, the components of the endovascular graftassembly 12 and the corresponding delivery components 24, 26, and 28 forthe endograft components are supplied sterile to the user.

As further shown in FIG. 2, the kit 40 comprises an additional package50 that provides the steerable endovascular guide 30 and at least oneassociated components; namely, the obturator 32. The kit 40 alsocomprises an additional package 48 that provides the endovascular stapleapplier 38 and at least one associated component; namely, a cassette 34holding a plurality of endovascular staples 36. Housed within thepackages 48 and 50, the steerable endovascular guide 30 and theendovascular staple applier 38 and their associated components aresupplied sterile to the user.

Further details of a representative construction of the contents of thepackages will now be described.

1. The Endovascular Graft

a. The Main Body

In a representative embodiment (see FIG. 3A), the main body 18 of theendovascular graft is a multi-lumen endograft comprising two primarycomponents: a graft 60 made of a biocompatible material, e.g.,polyester, ePTFE, etc.; and one or more stents or scaffolds 62 made of abiocompatible metal or plastic material, e.g., Stainless steel,nickel-titanium (Nitinol), etc.

In a representative embodiment, the preferred length of the main body 18is between 5 cm and 14 cm and most preferably between 7 cm and 10 cm.Desirably, different dimensions for the diameter of the main body 18 areprovided to accommodate different anatomic dimensions of patients.

As illustrated, the multi-lumen endograft is a tube at the proximal end,which separates into two distal ipsilateral and contralateral lumens 64and 66. The ipsilateral and contralateral lumens 64 and 66 are separatedby a septum 68 or “shared wall” between them. The septum 68 extends thelength of the ipsilateral lumen 64 (in the representative embodiment,approximately 3 cm).

The main body 18 includes a proximal sealing stent 70, e.g., withdiamond or “V” shaped cells, which is sewn to the inside proximal end ofthe graft e.g., with braided or monofilament suture. The proximalsealing stent 70 is sized and configured to ensure secure apposition tothe vessel wall just below the renal arteries. The stent 70 preferablyextends beyond the fabric 0 mm to 15 mm and most preferably extends 1 mmto 10 mm .

The main body 18 includes a distal locking stent 72 located in each ofthe two lumens 64 and 66 at the distal end of the main body 18. Thestents 72 are sewn to the graft, e.g., with braided or monofilamentsuture. The distal locking stents 72 of the main body 18 engage with thetape covering the proximal spiral stent 86 on the lumen extensions 20and 22 (see FIG. 3B) to help prevent component separation and providesupport to the lumen openings of the main body 18.

Predetermined arrays of radiopaque markers made from biocompatiblematerials with high radiopacity (e.g, tantalum, platinum or gold) aredesirably attached to the main body 18 to assist with visualizationunder fluoroscopy. The markers, like the stents, are sewn to the graft,e.g., with braided or monofilament suture or can be attached to thestent. The arrays can vary. In the illustrated embodiment, there are two(2) long contralateral side markers 74; three (3) short ipsilateral sidemarkers 76; four (4) proximal stent marker bands 78; five (5) distallocking stent marker bands 80; and an insertion depth marker 82 near theproximal end of the septum 68 for positioning of the lumen extension.

Further details of representative constructions of the main body 18 ofthe endovascular graft assembly 12 can be found in co-pending, commonlyowned U.S. patent application Ser. No. 11/254,444, filed Oct. 20, 2005,and entitled “Devices, Systems, and Methods for Prosthesis Delivery andImplantation, Including a Prosthesis Assembly,” which is incorporatedherein by reference.

b. The Lumen Extensions

In a representative embodiment (see FIG. 3B), each lumen extension 20and 22 is sized and configured to be inserted into the correspondingipsilateral and contralateral lumens of the main body 18, to completethe assembly of the endovascular graft 12 (see FIG. 3C). The lumenextensions 20 and 22 can be provided in various lengths and diameters todifferent anatomic dimensions of patients.

In a representative embodiment, each lumen extension comprises abiocompatible material 84, e.g., polyester, ePTFE, etc, and two stent orscaffold components 86 and 88 made of a biocompatible metal or plasticmaterial, e.g., Stainless steel, nickel-titanium (Nitinol), etc.

The first stent component 86 comprises a continuous, spiral sinusoidalstent that runs the length of the lumen extension 20 and 22. The spiralstent component 86 is sized and configured to prevent kinking andmaintain patency of the graft. The stent component can be sewn to thegraft, e.g., with braided or monofilament suture. The proximal region ofthe spiral stent is further covered with material, e.g., polyester,ePTFE, etc. The covered proximal region 90 is sized and configured toengage the locking stent 72 in the main body 18 (see FIG. 3C) to preventseparation of the lumen extension from the main body 18. The coveredproximal region 90 also serves to prevent the metallic stent componentsfrom coming into contact with one another.

The other stent component 88 of each lumen extension comprises a distalsealing stent. The stent component 88 can be sewn to the graft, e.g.,with braided or monofilament suture. The distal sealing stent 88 issized and configured to ensure good apposition of the lumen extension tothe wall of the iliac artery. The distal sealing stent 88 preferablyextends beyond the distal end of the fabric portion of the lumenextension 0 mm to 15 mm and most preferably extends 1 mm to 10 mm .

Predetermined arrays of radiopaque markers made from biocompatiblematerials with high radiopacity (e.g, tantalum, platinum or gold) aredesirably attached to each lumen extension to assist with visualizationunder fluoroscopy. The markers, like the stents, can be sewn to thegraft, e.g., with braided or monofilament suture or can be attached tothe stent. The arrays can vary. In the illustrated embodiment (FIG. 3B),there is a proximal insertion depth marker 92 at the proximal end of thegraft material and a distal marker 94 at the distal end of the graftmaterial.

Further details of representative constructions of the lumen extensions20 and 22 of the endovascular graft assembly can be found in co-pending,commonly owned U.S. patent application Ser. No. 11/254,444, filed Oct.20, 2005, and entitled “Devices, Systems, and Methods for ProsthesisDelivery and Implantation, Including a Prosthesis Assembly,” which isincorporated herein by reference.

2. Endovascular Graft Delivery Components

a. The Main Body Delivery System

i. General Overview

The main body 18 of the endovascular graft assembly 12 is preloaded intothe main body delivery system 24 (see FIG. 4A), which is a single usecomponent that is supplied to the user within its package 42 in asterile condition (see FIG. 2). The main body delivery system 24 issized and configured to facilitate accurate placement of the main body18 of the endovascular graft assembly 12 and to allow the physician tomaintain control of the main body 18 while the endovascular staples 36are applied.

In the illustrated embodiment (see FIG. 4A), the main body deliverysystem 24 comprises a delivery catheter 96 and a control handle 98coupled to the proximal end of the delivery catheter 96. The deliverycatheter 96 (see FIG. 4D) comprises a flexible inner assembly 100 and anouter graft retention jacket 102. The inner assembly 100 carries at itsdistal-most end a flexible radiopaque tracking nosecone 104.

When preloaded (see FIG. 4D), the main body 18 of the endovascular graftassembly 12 is attached to the inner assembly 100 in three locations.Just proximal of the nosecone 104 (i.e., toward the handle 98), the mainsealing stent 70 of the main body 18 is secured by a releasable sutureS1 to the inner assembly 100. Also just proximal of the nosecone 104,the inner assembly 100 includes a set of main body stabilizing arms 106.In the illustrated embodiment, there are three stabilizing arms 106. Theproximal end of the preloaded main body 18 of the endovascular graftassembly is attached to the three stabilizing arms by three releasablepull wires S2, each threaded through eyelets in a respective one of thedistal ends of the stabilizing arms 106 and through adjacent graftmaterial. The distal end of the ipsilateral lumen 66 of the preloadedmain body 18 is also attached to the inner assembly 100 by a releasablesuture S3. These sutures and release wires S1, S2, and S3 secure themain body 18 of the endovascular graft assembly 12 to the inner assembly100 for deployment to the targeted implantation site.

Separate wires 108, 110, and 112 extend from the handle 98 along theinner assembly 100. The separate release wires 108 and 112 areindependently coupled to the sutures S1 holding the proximal sealingstent 70 (release wire 108) and the suture S3 at the distal end of theipsilateral lumen 66 (release wire 112). The release wires 110 arecontinuations of the release wires S2 threaded through the stabilizingarms 106 (as previously described), so that, in the illustratedembodiment, there are actually three release wires 110, one for each arm106. Controls 114, 116, and 118 on the handle 98 are coupled to theseparate release wires 108, 110 (commonly coupled to the three wires),and 112, as will be described in greater detail later, to independentlyrelease the sutures or release wires at one location, withoutnecessarily releasing the sutures or release wires at another location.The separate and independently controllable release wires 108, 110, 112and make it possible to release of the main body 18 of the endovasculargraft assembly 12 in a prescribed order, to deploy the main body 18 ofthe endovascular graft assembly 12 in a desired sequence during thegraft deployment process, as will be described in greater detail later.

The graft retention jacket 102 is sized and configured to slide over andalong the inner assembly 100 from an advanced position over the mainbody 18 of the preloaded endovascular graft assembly 12 (shown inphantom Lines in FIG. 4E) to a retracted position spaced away from themain body 18 of the preloaded endovascular graft assembly 12 (shown insolid lines in FIG. 4E). A radiopaque marker 120 is positioned at theleading edge of the graft retention jacket 102 to assist invisualization under fluoroscopy. A jacket control mechanism 122 coupledto controls 124 and 126 on the handle 98 affects retraction of the graftretention jacket 102 in a stepwise fashion—using first control 124 andthen control 126, as will be described later—as well as there-advancement of the retention jacket 102 using the single control 126after the main body 18 has been fully deployed and it is time towithdraw the delivery system.

When in its advanced position, the graft retention jacket 102 protectsthe preloaded main body 18 of the endovascular graft assembly 12 as itis advanced through the patient's vasculature. When in its retractedposition, the graft retention jacket 102 frees the preloaded main body18 of the endovascular graft assembly 12 for deployment by operation ofthe controls 124 and 126 on the handle 98 during the graft deploymentprocess.

The actuating components on the control handle 98 (see FIGS. 4B and 4C)include a jacket retraction knob 124 and a jacket retraction slide 126,which are coupled to the jacket control mechanism 122 just described (asshown in FIG. 4D). The jacket retraction knob 124 is actuated byrotation and is coupled to a rack and pinion component of the jacketcontrol mechanism 122 within the handle 98. The rack and pinioncomponent applies a mechanical advantage in response to rotation of theknob 124 sufficient to overcome the initial resistance of the graftretention jacket 102 to axial movement beyond the proximal sealing stent70 of the main body 18 of the endovascular graft assembly 12. Once freeof the proximal sealing stent 70, the rack and pinion component of thejacket control mechanism 122 is automatically released from the jacketretraction knob 124 (the knob 124 will accordingly spin freely), andsubsequent control passes to the jacket retention slide 126. Pulling onthe jacket retention slide 126 (which does not provide a mechanicaladvantage) suffices to complete the retraction of the jacket 102. Thiscontrol sequence provides the physician with tactile feedback during theretraction of the jacket 102. After retracted in this manner, the jacket102 can be advanced back toward the nosecone 104 using the jacket slide126 when it is time to withdraw the delivery system.

The actuating components on the control handle (see FIGS. 4B and 4C)also include a proximal sealing stent release slide 114, a graft releaseslide 116, and an ipsilateral lumen release slide 118. The proximalsealing stent release slide 114 is coupled to the release wire 110 forthe proximal sealing stent 70 (see FIG. 4D). The graft release slide 116is coupled to the three separate release wires 110 for the stabilizingarms 106 (also shown in FIG. 4D). The ipsilateral lumen release slide118 is coupled to the separate release wire 112 for the distal end ofthe ipsilateral lumen 66 (as further shown in FIG. 4D).

Once the graft retention jacket 102 is retracted (as just described),pulling on the proximal sealing stent release slide 114 opens theproximal sealing stent 70. Despite opening the proximal sealing stent70, the proximal and ipsilateral ends of the main body 18 of theendovascular graft assembly 12 remain attached to the inner assembly 100of the endovascular graft delivery system. The physician maintainscontrol of the main body 18 of the endovascular graft assembly 12 forfurther final positioning and for the application of the staples 36, aswill be described in greater detail later.

Once positioned in a desired location and/or after insertion orimplantation of staples to secure the main body 12 to the vessel wall,pulling on the graft release slide 116 releases the proximal end of themain body 18 of the endovascular graft assembly 12 from the stabilizingarms 106. Despite opening the proximal sealing stent 70 and thestabilizing arms, the physician still maintains control of theipsilateral end of the main body 18 of the endovascular graft assembly,which remains attached to the inner assembly 100. Next pulling on theipsilateral lumen release slide 118 opens and releases the ipsilaterallumen 66 from the delivery catheter 96.

If desired, and as shown in phantom lines in FIG. 4A, a stationary outerjacket 220 may be provided that extends for a distance from the proximalend of the handle 98 over the delivery catheter 96 (the jacket 102)slides within the stationary outer jacket 220). The stationary jacket220 provides a seal interface with a hemostatic valve of the introducersheath at the access site. The stationary jacket 220 can be made of asuitable medical grade plastic, such as Fluroinated Ethylene Propylene(FEP) as non-limiting example. The stationary outer jacket 220 providescolumn strength and lubricity to reduce friction during slidingactuation of the jacket 102.

The delivery catheter 96 is desirably sized to present a minimumdiameter according to the diameter of the main body 18 of theendovascular graft assembly 12 it carries. The delivery catheter 26 isdesirably sized and configured with a lumen accommodating conventionalover-the-wire delivery within a patient's vasculature, e.g., using aconventional 0.035 or 0.038 inch guide wire. In representativeembodiment, the overall length of the delivery catheter is preferablybetween 40 and 120 cm and most preferably between 50 and 90 cm.

Further details of representative constructions of a main body deliverysystem 24 can be found in co-pending, commonly owned U.S. patentapplication Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled“Devices, Systems, and Methods for Prosthesis Delivery andImplantation,” which is incorporated herein by reference.

ii. Hemostasis Control

In a representative embodiment (see FIG. 5A), the proximal end of thehandle 98 (near the sliding controls 114, 116, and 118 just described)includes a hemostatic seal assembly 128. As FIG. 5D shows, a flushpassage 130 (for conveying heparinized saline to flush the deliverycatheter 96 prior to deployment) communicates with the space between theinner assembly 100 and jacket 102 through the hemostatic seal assembly128. As FIG. 5D also shows, the individual release wires 108, 110, and112 for the proximal sealing stent release slide 114, the graft releaseslide 116 (one release wire 110 for each stabilizing arm 106), and theipsilateral lumen release slide 118, as previously described, also passfrom the slide controls 114, 116, and 118 within the handle in a sealedfashion through the hemostatic seal assembly 128 for passage along theinner assembly 100 to the distal end of the delivery catheter 96, wherethey connect to their respective components, as previously described.The hemostatic seal assembly 128 allows flushing to occur and preventsblood, which can enter the space between the outer jacket 102 and theinner assembly 100 catheter tube during use, from entering the interiorof the handle 98.

In the illustrated embodiment (see FIGS. 5B and 5C), the hemostatic sealassembly 128 includes first and second substantially rigid sealcomponents 132 and 134, made e.g. of an inert material. The first sealcomponent 132 comprises a center post 136 and a collar 138 that extendsradially from an end of the post 136. The collar 138 forms a mount forcoupling the hemostatic seal assembly 128 within the confines of thehandle 98, as FIG. 5D shows.

The center post 136 defines a passage that sealingly engages the flushpassage 130 of the delivery catheter 96, to provide a fluid seal.

The second seal component 134 comprises an annular ring that fits aboutthe post. As further shown in FIGS. 5B and 5C, the hemostatic sealassembly 128 further includes an annular septum or gasket 140 that alsofits about the post 136. When assembled, the gasket 140 is sandwichedbetween the second seal component 134 and the collar 138 of the firstseal component 132. The gasket 140 is made of a soft material, likesilicone rubber. The collar 138 and the second seal component 134include coaxial through-holes or guide tubes 142 to accommodate passageof the various release wires 108, 110, and 112 through the annulargasket 140. The through-holes 142 act as bearing surfaces or guides forthe release wires 108, 110, and 112 on opposite sides of the annulargasket 140.

The gasket 140 provides a dynamic fluid seal for the release wires 108,110, and 112. The fluid seal is maintained even if a release wirebecomes tensioned during use in a non-axial direction. The length anddiameter of the bearing surfaces of the through holes 142 and thethickness of the annular gasket 140 can vary depending upon the diameterof the release wires 108, 110, and 112 and direction or angle therelease wires 108, 110, and 112 make as they exit the bearing throughholes 142, to prevent tear out or sawing of the material of the gasket140.

b. The Lumen Extension Delivery System

Each lumen extension 20 and 22 of the endovascular graft assembly ispreloaded into a lumen extension delivery system, respectively 26 and28(see FIG. 6A), each of which is a single use component that issupplied to the user within its package 44 and 46 in a sterilecondition. Each lumen extension delivery system 26 and 28 is sized andconfigured to facilitate accurate placement of its lumen extension 20and 22 of the endovascular graft assembly 12.

In the illustrated embodiment (see FIG. 6A), each lumen extensiondelivery system 26 and 28 comprises a delivery catheter 144 and acontrol handle 146 coupled to the proximal end of the delivery catheter144. The delivery catheter 144 (see FIG. 6D) comprises a flexible innerassembly 148 and an outer graft retention jacket 150. The inner assembly148 carries at its distal-most end a flexible radiopaque trackingnosecone 152.

When preloaded (see FIG. 6D), the lumen extension 20 or 22 of theendovascular graft assembly is attached to the inner assembly 148 by areleasable suture S4 at the proximal end of the spiral stent 86. Arelease wire 154 extends from the handle 98 along the inner assembly 148and is coupled to the suture S4 holding the proximal end of the spiralstent 86. A sliding control 156 on the handle 146 is coupled to therelease wire 154 (as will be described in greater detail later), torelease the suture S4 and thereby release of the lumen extension 20 or22 of the endovascular graft assembly 12 from the inner assembly 148during the graft deployment process, as will be described in greaterdetail later.

The graft retention jacket 150 is sized and configured to slide over andalong the inner assembly 148 from an advanced position over thepreloaded lumen extension 20 or 22 of the endovascular graft assembly 12(shown in phantom Lines in FIG. 6D) to a retracted position spaced awayfrom the preloaded lumen extension 20 or 22 of the endovascular graftassembly 12 (shown in solid lines in FIG. 6D). A radiopaque marker 158is positioned at the distal end of the graft retention jacket 150 toassist in visualization under fluoroscopy. A control mechanism 160coupled to a sliding control 162 on the handle 146 affects advancementand retraction of the graft retention jacket 150, as will be describedlater.

When in its advanced position, the graft retention jacket 150 protectsthe preloaded lumen extension 20 or 22 of the endovascular graftassembly 12 as it is advanced through the patient's vasculature. When inits retracted position, the graft retention jacket 150 frees thepreloaded lumen extension 20 or 22 of the endovascular graft assembly 12for deployment by operation of the sliding control 162 on the handle 98during the graft deployment process.

The actuating components on the control handle 146 (see FIGS. 6B and 6C)include a jacket retraction knob 162 (coupled to the jacket controlmechanism 160) and a proximal spiral stent release slide 156 (coupled tothe release wire 154 just described (as shown in FIG. 6D). Pulling onthe jacket retraction slide 162 suffices to retract the jacket 150. Oncethe graft retention jacket 150 is retracted (as just described), pullingon the proximal spiral stent release slide 156 opens and releases thelumen extension 20 or 22 from the inner assembly 148.

A stationary outer jacket 220 may also be provided for the lumenextension delivery systems 26 and 28 (as shown in phantom lines in FIG.6A). As previously described with respect top the main body deliverysystem 24, the stationary outer jacket 220 extends for a distance fromthe proximal end of the handle 146 over the delivery catheter 144 (thejacket 150) slides within the stationary outer jacket 220). Thestationary jacket 220 provides a seal interface with a hemostatic valveof the introducer sheath at the access site. As previously described,the stationary jacket 220 can be made of a suitable medical gradeplastic, such as Fluroinated Ethylene Propylene (FEP) as non-limitingexample. The stationary outer jacket 220 provides column strength andlubricity to reduce friction during sliding actuation of the jacket 150.

Each lumen extension delivery catheter 144 is desirably sized to presenta minimum diameter according to the diameter of the lumen extension 20or 22 of the endovascular graft assembly 12 it carries. The deliverycatheter 144 is desirably sized and configured with a lumenaccommodating conventional over-the-wire delivery within a patient'svasculature, e.g., using an appropriately sized guide wire. Inrepresentative embodiment, the over-all length of the lumen extensiondelivery catheter 144 is preferably between 40 and 120 cm and mostpreferably between 50 and 90 cm.

The lumen extension delivery catheter can include a hemostatic valveassembly of the type previously described and as shown in FIGS. 5A to5D.

Further details of representative constructions of a lumen extensiondelivery system can be found in co-pending, commonly owned U.S. patentapplication Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled“Devices, Systems, and Methods for Prosthesis Delivery andImplantation,” which is incorporated herein by reference.

C. Endovascular Stapling System

The endovascular stapling system 16 comprises steerable endovascularguide 30 and a companion obturator 32 (see FIGS. 7A and 7B) forover-the-wire, intravascular deployment of the steerable endovascularguide 30. The endovascular stapling system 16 also comprises a pluralityof endovascular staples 36 (FIG. 8A) and, desirably, a cassette 34 forholding the staples 36 (see FIG. 8B), as well as an endovascular stapleapplier 38 (see FIGS. 9A and 9B).

d. Steerable Endovascular Guide and Companion Obturator

The steerable endovascular guide 30 is a single use component that issupplied with a companion obturator 32 to the user within its package 50in a sterile condition. The steerable endovascular guide 30 is sized andconfigured to direct the endovascular staple applier 38 to the desiredlocation for implantation of one or more endovascular staples 36.

The steerable endovascular guide 30 (see FIGS. 7A and 7B) includes aguide tube 164 and a handle 166 coupled to the proximal end of the guidetube 164. The guide tube defines an open interior lumen 168accommodating passage of the obturator 32 (during deployment) and theendovascular staple applier 38 (during use).

The distal portion of the guide tube 164 can be deflected in onedirection (as shown in phantom lines in FIG. 7A) and straightened by asteering wire (not shown) coupled to a rotational deflector knob 170 onthe handle 166. In a representative embodiment, the over-all length ofguide tube 164 and handle 166 is preferably between 40 and 120 cm andmost preferably between 50 and 90 cm, and the length of the deflectabletip is preferably between 1 and 10 cm and most preferably between 2 and5 cm. A C-shaped radiopaque marker 172 is located at the distal tip ofthe guide tube 164 to aid in orientation under fluoroscopy.

In a representative embodiment, the obturator 32 is desirably sized andconfigured with a lumen 174 accommodating conventional over-the-wiredelivery within a patient's vasculature, e.g., using an appropriatelysized guide wire.

Further details of representative constructions of a steerableendovascular guide 30 can be found in co-pending, commonly owned U.S.patent application Ser. No. 11/254,619, filed Oct. 20, 2005, andentitled “Devices, Systems, and Methods for Guiding an Operative Toolinto an Interior Body,” and co-pending, commonly owned U.S. patentapplication Ser. No. 11/254,116, filed Oct. 20, 2005, and entitled“Devices, Systems, and Methods for Prosthesis Delivery andImplantation,” which are both incorporated herein by reference.

B. The Endovascular Staple and Companion Cassette

The endovascular staple 36 (see FIG. 8A) is a single use component thatis supplied, desirably in a companion cassette, to the user within apackage in a sterile condition. The endovascular staple 36 is sized andconfigured to attach the endovascular graft assembly 12 to a vesselwall.

In the illustrated embodiment (see FIG. 8A) the endovascular staple 36comprises a main staple body 176 that is helical-shaped. Thehelical-shape allows the endovascular staple 36 to pierce and engagetissue in response to rotation of the main staple body 176, therebysecuring attachment of the endovascular graft assembly 12 to a vesselwall.

In a representative embodiment, the main staple body 176 is manufacturedfrom medical grade wire having a diameter of from 0.1 mm to 1 mm . In arepresentative embodiment, the endovascular staple 36 is approximatelybetween 2 mm to 12 mm in over-all length and approximately fromapproximately 1 mm to 10 mm in maximum diameter. The leading end 178 ofthe main staple body 176 is desirably sharpened to facilitate atraumaticdeployment through the graft materials and vessel wall. The proximal end180 of the main staple body 176 is desirably closed to preventover-penetration of the endovascular staple 36.

Desirably, a plurality of staples 36 (e.g., ten) are provided in acassette 34 (see FIG. 8B), to allow easy and accurate loading into theendovascular staple applier 38. The cassette 34 includes a base 208having a plurality of spaced apart staple ports or stations 210, eachsized to house a staple 36. A cover 212 rotates on the base 208 (seeFIG. 8C). The cover 212 overlies the ports 210, closing them, except foran open notch region 214, which permits access to a single one of theports 210. In use, an operator rotates the cover 212 to expose one port210 and the staple 36 it contains. The operator operates the stapleapplier 38 to load the staple 36 from the exposed port 210, as will bedescribed in greater detail. After implanting the withdrawn staple 36,the operator rotates the cover 212 to expose another one of the ports210 and the staple 36 it contains. The operator again operates thestaple applier 38 to load the staple 36 from the exposed port 210 forimplantation. In this way, the cassette 34 aids the operator in loadingindividual staples on the staple applier 36 for implantation in a singlefire (one at a time) fashion.

Further details of representative constructions of an endovascularstaple 36 and companion cassette 34 can be found in co-pending, commonlyowned United States patent application Ser. No. 11/255,116, filed Oct.20, 2005, and entitled “Devices, Systems, and Methods for ProsthesisDelivery and Implantation,” which is incorporated herein by reference.

C. Endovascular Staple Applier

1. Overview

The endovascular staple applier 38 (see FIGS. 9A and 9B) is a single usecomponent that is supplied to the user within a package 48 in a sterilecondition. In the illustrated embodiment, the endovascular stapleapplier 38, a supply of endovascular staples 36, and the staple cassette34 are provided, for the sake of convenience, in a single package 48.The endovascular staple applier 38 is sized and configured to passthrough the lumen 168 of the steerable endovascular guide tube 164 andto be selectively operated to implant one or more endovascular staples36 through the graft materials and vessel wall.

In the illustrated embodiment, the endovascular staple applier 38comprises an applier catheter 182 and a control handle 184 coupled tothe end of the applier catheter 182. The applier catheter 182 carries arotationally driven member 186 at its distal end. A battery poweredmotor 188 enclosed within the handle 184 is coupled to the driven member186, to selectively rotate the driven member 186 either in a forward(e.g., clockwise) direction and reverse (e.g., counterclockwise)direction. A control circuit 190 in the handle 184 is coupled to themotor 188 and to a forward control button 192 and a reverse controlbutton 194 on the handle. The control circuit 190 governs operation ofthe operation of the motor 188 according to pre-programmed operatingparameters in response to user commands received by manipulation of thebuttons 192 and 194.

In use (see FIGS. 10A to 10H), an endovascular staple 36 is loaded intothe driven member 186 from the cassette 34, e.g., by placing the distalend of the applier catheter 182 into an exposed staple port 210 in thecassette 34 and pressing the reverse control button 194 (FIG. 10A). Thenow loaded endovascular staple applier 38 is passed through the guidetube 164 of the endovascular guide 30 (FIG. 10B), which has beenmanipulated beforehand to be at an intended implantation site for theendovascular staple 36.

Once the endovascular staple applier 38, loaded with a staple, ispositioned at the desired location (FIG. 10C), the physician presses theforward control button 192 to command rotation of the endovascularstaple 36 in the forward direction (i.e., into tissue).

The control circuit 190 is desirably pre-programmed to require atwo-stage implantation process. The first stage commands only a partialimplantation of the staple 36. In the first stage, the physician isallowed to ascertain whether the staple 36 is placed correctly at thedesired location and that the desired located is suitable forimplantation of the staple 36. While in the first stage, the physicianis allowed to retract the staple 36 (by pressing the reverse controlbutton 194) and to re-position the staple 36.

The control circuit 190 commands a full final deployment of the staple36 only after a deliberate entry of the second stage. In the first andsecond stages, the control circuit 190 generates audible tones andvisual indicators e.g., blinking lights, during operation of the motor188, to indicate the position of the staple and available direction ofmotion.

Once the staple 36 is implanted, the endovascular staple applier 38 iswithdrawn through the endovascular guide. The cassette cover 212 isrotated to reveal another staple port 210 and the staple 36 it contains.The staple applier 38 is reloaded. The endovascular guide 30 ismanipulated to another desired implantation site, and the endovascularstaple applier 38 (reloaded with another staple 36) is redeployed andoperated in the manner just described. The endovascular staple applier38 is intended to be loaded, deployed, and reloaded in this way multipletimes for a single patient.

Further details of representative constructions of an endovascularstaple applier 38 and methods of its use can be found in co-pending,commonly owned U.S. patent application Ser. No. 11/254,950, filed Oct.20, 2005, and entitled “Devices, Systems, and Methods for ProsthesisDelivery and Implantation, Including the Use of a Fastening Tool” whichis incorporated herein by reference.

2. Tracking the Relative Position of the Endovascular Staple Applier inthe Endovascular Guide

Desirably, the endovascular staple applier 38 includes indicia 196,which is visible to a naked eye (i.e., without resort to fluoroscopicvisualization or other visualization techniques that augment humanvision) the indicates the extent to which the driven distal end 186 ofthe applier catheter 182, which carries the endovascular staple 36,resides within the guide tube 164 of the steerable endovascular guide30. In particular, the visible indicia 196 indicates when the drivendistal end 186 of the applier catheter 182 and the staple 36 it carrieshave arrived at a predetermined location within the guide tube near tobut still within the distal end of the guide tube 164. In this way (seeFIG. 11C), the physician can quickly and accurately ascertain, withoutresort to fluoroscopic visualization, that the distal end of the appliercatheter 182, and the endovascular staple 36 it carries, are positionedwholly within the confines of the guide tube 164, ready for finaldeployment, once the guide tube 164 is placed at the intendedimplantation site. The visible indicia 196 can also indicate to extendto which the driven distal end 186 of the applier catheter 182 has beenextended outside the distal end of the guide tube 164.

In the illustrated embodiment (see FIG. 11A), the indicia 196 comprisesvisible material or markings on the most proximal section of the appliercatheter 182, adjacent the handle 184, that is marked or coloreddifferently or is otherwise differentiated from the remainder of theapplier catheter 182. In a representative example, a prescribed lengthof contrast-colored tubing 198 can be placed at the most proximal end ofthe applier catheter 182, where it exits the handle 184.

The contrast-color tubing 198 has a prescribed length. The distal end ofthe tubing 198 marks a line of differentiation between the tubing 198and the remainder of the applier catheter 182. The length is selected sothat the distal end of the tubing 198 registers with the insertionport/hemostatic seal 200 on the handle 166 of the steerable endovascularguide 30 (see FIG. 11B) when the driven distal end 186 of appliercatheter 182 rests at a desired inset distance d within the distal endof the guide tube 164 (see FIG. 11C).

In this way, the indicia 196 indicates when the applier catheter 182 hasreached a desired insertion depth within the guide tube, and is ready tobe further advanced beyond the guide tube 164 to implant theendovascular staple 36. The contrast-color tubing 198 may furtherinclude additional markings M along its length by which the physiciancan gauge advancement of the applier catheter 182 beyond theendovascular guide 20.

The indicia 196 makes it possible for the physician, without resort tofluoroscopic visualization, to always know whether the endovascularstaple 36 is within or outside the endovascular guide 30.

3. The Motor Control Circuit

In a representative embodiment (see FIG. 13A), the control circuit 190for the motor includes an optical encoder 250 coupled to a countingfunction 252, to enable counting the revolutions of the battery poweredmotor 188. The control circuit 190 also includes a sensing function 254that senses the magnitude of current being drawn by the motor 188, forderiving torque that the motor 188 is encountering. The control circuit190 also includes a comparison function 256 that compares the magnitudeof the sensed torque (current) with set torque limits in either theforward or reverse direction, to change the state of operation shouldexcess torque conditions be encountered.

The control circuit 190 carries embedded code, which expressespre-programmed rules or algorithms under which different operationstates are entered and motor command signals are generated in responseto input from the external control sources and the counting, sensing,and comparison functions. The pre-programmed rules or algorithms of thecontrol circuit 190 are designed to conserve power consumption, placingthe circuit into a standby (wait) mode between staple loading anddeployment cycles. This makes it possible to power up the staple applierjust once and to leave the staple applier on during an entire procedure,avoiding time consumed in repeated power ups and power downs. Thepre-programmed rules or algorithms of the control circuit also dictatethat a desired sequence of steps is faithfully followed in loading,deploying, and reloading the staples, prompting the physician at theinitiation of each step and not allowing any short-cuts or deviationsalong the way.

Features of the pre-programmed rules or algorithms of a representativecontrol circuit 190 for the staple applier will now be described ingreater detail.

Power Up/System Self-Check

In a representative implementation (see FIG. 13B), the pre-programmedrules or algorithms of the control circuit 190 enter a POWER UP statewhen an operator enters a prescribed power up command, e.g., when theoperator presses and holds the reverse control button 194 for aprescribed amount of time. In the POWER UP state, the pre-programmedrules or algorithms of the control circuit 190 first check batteryvoltage against a set minimum. The POWER UP state proceeds if thebattery voltage exceeds the set minimum. Otherwise, the pre-programmedrules or algorithms of the control circuit 190 enter a LOW BATTERY FATALstate.

Absent a LOW BATTERY FATAL state, the pre-programmed rules or algorithmsof the control circuit 190 enable the optical encoder and drive themotor 188 in a forward direction for a set period of time. The countingand sensing functions of the control circuit 190 count the number ofrevolutions and sense forward current. If the forward current exceeds aset maximum current level (as determined by the comparison function),the pre-programmed rules or algorithms of the control circuit 190 entera FORWARD TORQUE FATAL state. Otherwise, the sensed forward current isregistered by the pre-programmed rules or algorithms of the controlcircuit 190 as a base line for forward torque.

Absent a FORWARD TORQUE FATAL state, the pre-programmed rules oralgorithms of the control circuit 190 enable the optical encoder andcounting function, and drive the motor 188 in a reverse direction for aset period of time. The counting function of the control circuit 190counts the number of revolutions, while the sensing function sensesreverse current. If the reverse current exceeds a set maximum currentlevel (as determined by the comparison function), the pre-programmedrules or algorithms of the control circuit 190 enter a REVERSE TORQUEFATAL state. Otherwise, the sensed reverse current is registered by thepre-programmed rules or algorithms of the control circuit 190 as a baseline for reverse torque.

Audible tones and visual indicators (e.g. blinking lights) coupled tothe control circuit 190 desirably accompany the POWER UP state as thesystem self-check is accomplished. If no fatal states are encounteredduring the POWER UP sequence, the pre-programmed rules or algorithms ofthe control circuit 190 enter a READY TO LOAD state. The pre-programmedrules or algorithms of the control circuit 190 enable a ready to loadprompt, e.g., blinking a reverse green arrow 202 (see FIG. 9B), toindicate to the user that the endovascular staple applier 38 is ready toload the first endovascular staple. If a fatal state is encountered, thepre-programmed rules or algorithms of the control circuit 190 enable adifferent prompt, e.g., illuminating a red error light 204 (see FIG.9B), indicating that the endovascular staple applier 38 has encounteredan error.

In addition, there are other checks that can be performed during thePOWER UP state, including checking the encoder and the watchdog functionfor operation.

In a representative implementation, the pre-programmed rules oralgorithms of the control circuit 190 allow the operator to clear theerror state one time, e.g., by pressing the forward control button 192.After the error has been cleared, the self-check sequence of the POWERUP state will reinitiate. If during the second self check sequence, afatal state is again encountered, the pre-programmed rules or algorithmsof the control circuit 190 either disable the endovascular stapleapplier 38 from use, or again enable the error prompt. In the latterinstance, the instructions for use 58 desirably will inform the operatornot to use an endovascular staple applier 38 that has encountered astart-up error twice.

Ready to Load State: Load Staple

After the staple applier has been powered up and is in the READY TO LOADstate, the operator is able to load the endovascular staple byinitiating a prescribed input command, e.g., by pushing the reversecontrol button 194. The distal end of the endovascular staple appliercatheter 182 is intended to be inserted into a staple port of thecassette at the time the input command is given.

When the prescribed input command is received, the pre-programmed rulesor algorithms of the control circuit 190 command the motor 188 to rotatein a reverse direction for a set time period and generates aconfirmation output with visual indicators (e.g., blinking the reversegreen arrow 202). The endovascular staple 36 will be drawn from thecassette 34 into the distal end of the staple applier 38.

The sensing function of the control circuit 190 senses the magnitude ofthe current drawn by the motor 188 as the staple 36 is being loaded ontothe distal end of the staple applier 38. Once a prescribed amount ofcurrent has been reached, the pre-programmed rules or algorithms of thecontrol circuit 190 consider the staple applier to have completed theloading state. The pre-programmed rules or algorithms of the controlcircuit 190 then automatically go into a UNWIND sequence, to reduce oreliminate amount of torque windup in the staple applier catheter anddrive shaft developed during the LOAD state. The pre-programmed rules oralgorithms of the UNWIND sequence run the motor in the reverse directionfrom the load direction a set number of turns and wait for a commandinput.

After the UNWIND sequence, the endovascular staple is presumed loaded,and the pre-programmed rules or algorithms of the control circuit 190enter a READY TO APPLY state. The pre-programmed rules or algorithms ofthe control circuit 190 generate a confirmation output, e.g., audibleand visual indicators (e.g., two short beeps and a forward green arrow206 will blink (see FIG. 9B) to prompt the next step, which is to deploythe staple 36.

The endovascular staple 36 is now loaded in the staple applier 38, andthe applier 38 can be removed from the cassette 34. The physician isdesirably urged by the instructions for use 58 to verify that theendovascular staple 36 is in place by visually inspecting the distal endof the applier 38.

When the staple applier 38 has been powered up and is in the READY TOLOAD state, the pre-programmed rules or algorithms of the controlcircuit 190 desirably do not accept any command other than the commandprescribed for loading (e.g., pushing the reverse control button 194).If an operator provides a contrary command, e.g., by pushing on theforward command button 192, the pre-programmed rules or algorithms ofthe command circuit will ignore the command. In this way, thepre-programmed rules or algorithms of the command circuit require anoperator to follow a prescribed sequence in operating the stapleapplier.

Ready to Apply State: Deploy Staple

When the pre-programmed rules or algorithms of the control circuit 190have entered the READY TO APPLY state, and the operator is ready todeploy the staple 36, the operator is able to deploy the endovascularstaple 36 by initiating a prescribed input command, e.g., by pressingthe forward control button 192. When the forward control button 192 ispushed, the pre-programmed rules or algorithms of the control circuit190 command the motor 188 to rotate in a forward direction for a setnumber of rotations (sensed by the counting function), which, accordingto the pre-programmed rules or algorithms, are less than the number ofrotations required to fully implant the staple. The pre-programmed rulesor algorithms of the control circuit 190 suspend operation of the motor188 at this point and await another input command. Thus, thepre-programmed rules or algorithms of the control circuit 190 onlypartially deploy the staple and generate a confirmation output, e.g.,four beeps and/or alternatively blinking the forward and reverse arrows202 and 206, prompting the operator to make a choice. This indicatesthat the operator may chose to continue deployment or to withdraw theendovascular staple back into the applier.

If the operator inputs a prescribed withdraw command, e.g., by pushingthe reverse control button 194, the pre-programmed rules or algorithmsof the control circuit 190 drive the motor 188 in the reverse directionfor a set number of rotations (sensed by the counting function), towithdraw the staple 36. The pre-programmed rules or algorithms of thecontrol circuit 190 then return to the READY TO APPLY state.

If the operator inputs a prescribed complete the implantation command,e.g. by pushing the forward control button 192, the pre-programmed rulesor algorithms of the control circuit 190 will drive the motor 188 in theforward direction for a set number of rotations (monitored by thecounting function), to complete the implantation of the staple. Thepre-programmed rules or algorithms of the control circuit 190 generate aconfirmation output, e.g., audio and visual indicators. Thepre-programmed rules or algorithms of the control circuit 190 return tothe READY TO LOAD state.

During the different operational states, the pre-programmed rules oralgorithms of the control circuit 190 continue to check battery voltageagainst a set minimum. The operational states proceed as described aslong as the battery voltage exceeds the set minimum. If, during anoperational state the battery voltage falls below the set minimum, thepre-programmed rules or algorithms of the control circuit 190 enter aLOW BATTERY FATAL state.

D. The Instructions for Use

The instructions for use 58 can direct use of catheter-based technologyvia a peripheral intravascular access site, such as in the femoralartery, optionally with the assistance of image guidance. Image guidanceincludes but is not limited to fluoroscopy, ultrasound, magneticresonance, computed tomography, or combinations thereof.

FIGS. 12A to 12P show a representative embodiment of the steps that arepresentative instructions for use 58 can incorporate or direct.

In a representative embodiment, the instructions for use 58 may includethe achievement of percutaneous vascular access by conventional methodsinto the femoral artery, for example. In this arrangement, the patientis placed on an imaging table, allowing fluoroscopic visualization fromthe aortic arch to the femoral artery bifurcations. Access is secured toboth contralateral and ipsilateral branches by standard techniques usingintroducer sheaths (which can be supplied as part of the kit 40). Usingfluoroscopic guidance, access to the patient's abdominal aorta can beachieved with an appropriately sized guide wire through each femoralaccess sites.

1. Position the Main Body Graft Assembly in the Targeted EndovascularTreatment Site

In this arrangement, the instructions 58 for use may include positioningof the main body 18 of the endovascular graft assembly to be deployed.The instructions may include a series of steps that can be followed tocarry out this portion of the procedure. These steps may include:

(i) after flushing the main body delivery system 24 with heparinizedsaline, positioning the main body delivery system 24 within an aorticaneurysm over the guide wire via the ipsilateral femoral access site,which has been previously established in conventional fashion (FIG.12A);

(ii) visualizing the proper rotation and orientation of the main body 18using the ipsilateral and contralateral radiopaque markers on the mainbody 18. As previously described, the main body 18 includes three (3)short markers 76 on the ipsilateral side and two (2) long markers 74 onthe contralateral side for this purpose. The two rows of markers 74 and76 should be parallel to each other and not cross. The main bodydelivery system 24 can be rotated for re-alignment of the main body 18of the graft assembly 12.

(ii) withdrawing the graft retention jacket 102 of the main bodydelivery system 24 by rotating the jacket retraction knob 124, until theknob 124 spins freely (which indicates that the rack and pinionmechanism has been released). This step only partially retracts thejacket 102 (about 63 mm ), unsheathing the proximal stent 70, with theremaining portion of the main body 18 still constrained within thejacket 102. The instructions may note that the proximal sealing stent 70will not open during retraction of the jacket 102.

(iii) completing the retraction of the graft retention jacket 102 bysliding the jacket retention slide 126 away from the patient. Theinstructions may note that the contralateral lumen of the main body 18is now fully open, while the proximal sealing stent 70 and ipsilaterallumen remain collapsed and connected to the main body delivery system 24(FIG. 12B);

(iv) verifying the position and orientation of the main body 18 usingthe radiopaque markers 74 and 76, to ensure that blood flow to the renalarteries is not obstructed and the main body 18 of the graft assembly 12is not twisted; and

(v) opening the proximal sealing stent 70 by retracting the proximalsealing stent release slide 114 (FIG. 12C). The instructions may notethat the proximal and distal ends of the main body 18 of theendovascular graft assembly 12 still remain secured to the main bodydelivery system 24. The physician thereby maintains control of theposition and orientation of the main body 18 of the graft assembly 12.

2. Deploy Endovascular Staples to Secure the Position of the Main Bodyof the Graft Assembly

The instructions for use 58 may next instruct securing of the positionof the proximal end of the main body 18 of the endovascular graftassembly using endovascular staples 36. The instructions may include aseries of steps that can be followed to carry out this portion of theprocedure. These steps may include:

(i) placing an exchange length appropriately sized guide wire via thecontralateral femoral access site into the abdominal aorta (FIG. 12D).The main body 18 of the endovascular graft assembly includes distal endradiopaque markers that outline the opening of the contralateral lumenof the main body 18. The guide wire is to be placed through this openingand its position verified using standard endovascular techniques.

(ii) inserting the obturator 32 into the lumen 168 of the steerableendovascular guide 30.

(iii) using fluoroscopic guidance, advancing the steerable endovascularguide 30 with the obturator 32 over the guide wire into a positionwithin the proximal neck of the aortic aneurism (FIG. 12E). The C-shapedradiopaque marker 172 located at the distal tip of the steerableendovascular guide 30 will aid in fluoroscopic visualization.

(iv) removing the guide wire.

(v) removing the obturator 32 to open the lumen 168 of the steerableendovascular guide 30 for passage of the endovascular staple applier 38.

(vi) deflecting the distal end of the steerable endovascular guide 30toward the first intended staple implantation area by rotating thedeflector knob, while observing with fluoroscopic guidance. Theinstructions may note that the C-shaped fluoroscopic marker 172 willappear as a straight line when the catheter is oriented laterally, as aright curve “(” when oriented anteriorly, and as a left curve “)” whenoriented posteriorly.

(vii) turning on the endovascular staple applier 38 by pressing andholding the reverse control button 194 for at least five (5) seconds.This initiates a self-checking sequence with audible tones and blinkinglights. At the end of this sequence, the reverse green arrow 202 will beblinking, indicating that the endovascular staple applier 38 is ready toload the first endovascular staple 36. The instructions may note that,if at the end of the self check sequence, the red error light 204 isilluminated, the endovascular staple applier 38 has encountered anerror. The error can be cleared by pressing the forward control button192. After the error has been cleared, the self check sequence willinitiate. If at the end of the second self check sequence, the red errorlight 202 is still illuminated, the endovascular staple applier 38 isnot functional and should not be used.

(viii) after flushing the inner lumen of the endovascular staple applier38 with heparinized saline via the flush port, loading the staple bypressing the reverse command button 194 on the handle. While the motor188 is running, insert the distal end of the endovascular staple appliercatheter 182 into the open staple port of the cassette 34. The reversegreen arrow 202 will blink, and the endovascular staple will be drawnfrom the cassette into the distal end of the staple applier 38. When theendovascular staple 36 is loaded, an audible tone (e.g., two shortbeeps) will be heard, and the forward green arrow 206 will blink. Thisindicates that the endovascular staple 36 is now preloaded in the stapleapplier 38, and the applier 38 can be removed from the cassette 34. Theinstructions may urge the physician to verify that the endovascularstaple 36 is in place by visually inspecting the distal tip of theapplier 38.

(ix) while stabilizing the control handle 166 of the endovascular guide30 relative to the patient, inserting the now-loaded endovascular stapleapplier 38 through the hemostatic seal at the proximal end of thesteerable endovascular guide control handle 166. The instructions maydirect the physician to observe the location of the visiblecontrast-color tubing 198 or other indicia on the proximal end of theapplier catheter 182 and to halt further insertion of the staple applier38 when the end of the contrast-color tubing 198 registers with theinsertion port/hemostatic seal on the handle of the steerableendovascular guide (as shown in FIG. 11B). This indicates that thedistal end of applier catheter 182 rests in a desired short insetdistance within the distal end of the guide tube 164 (as shown in FIG.11C).

(x) inserting and positioning the steerable endovascular guide 30 at thedesired location for endovascular staple implantation within a desiredstapling zone, e.g., between the marker bands on the proximal sealingstent 70 and the bottom edge of the proximal sealing stent 70. Theinstructions may note that the endovascular staples should be evenlydistributed around the circumference of the proximal sealing stent 70,typically about 4 to 6 endovascular staples per graft.

(xi) under fluoroscopic guidance, advancing the endovascular stapleapplier 38 through the steerable endovascular guide 30 until theendovascular staple applier 38 emerges from the distal end and contactsthe endovascular graft assembly 12. Slowly, continue to advance theendovascular staple applier 38 until resistance is felt, indicating thatthe endovascular staple applier 38 is firmly pushing against the mainbody 18 of the endovascular graft assembly 12 against the vessel wall.

(xii) using the control handle 184 of the endovascular staple applier38, pressing the forward control button 192 for achieving the firststage of endovascular staple deployment. The endovascular step willpartially deploy and pause. An audible tone is heard (e.g., four beeps)and the forward and reverse arrows 202 and 206 will alternatively blink,indicating that the operator may continue deployment or withdraw theendovascular staple 36 back into the applier 38. The instructions maynote that, in the event of a power loss when the staple 36 is partiallydeployed, the staple may be removed by manually rotating the handle 184and catheter 182 in a counter-clockwise direction until the staple 36disengages from the graft and tissue. The staple applier 38 can beremoved from the endovascular guide 30 in this condition.

(xiii) If the endovascular staple 36 is not in the desired location,pressing the reverse control button 194 to re-house the staple insidethe staple applier 38 for re-positioning.

(xiv) If the endovascular staple 36 is in the desired position,completing the final stage of staple deployment by pressing the forwardcontrol button 192 (FIG. 12F). When complete, an audible tone (e.g.,three beeps) is heard and the reverse green arrow 202 will be blinking.

(xv) using fluoroscopy, carefully and slowly retracting the endovascularstaple applier 38 away from the graft wall to ensure it is released fromthe deployed staple.

(xvi) removing the endovascular staple applier 38, leaving the steerableendovascular guide 30 in place.

(xvii) using fluoroscopy, visually confirming that the endovascularstaple 36 is in place.

(xviii) as needed, flush the steerable endovascular guide and the stapleapplier with heparinized saline to prevent clotting in the lumens.

(xix) rotating the head of the cassette 34 (as shown in FIG. 8C)clockwise to expose the next endovascular staple port. Load the nextendovascular staple in the manner described above.

(xx) repositioning the steerable endovascular guide 30 to the nextdesired implantation site for an endovascular staple 36. Desirably, thephysician straightens the steerable endovascular guide 30 betweenrotating in within the main body 18, to prevent accidental dislodgmentor movement of the main body 18.

(xxi) deploying the next endovascular staple 36 through the steerableendovascular guide 30 in the manner described above. Typically, 4 to 6endovascular staples, evenly distributed about the circumference of themain body 18, will serve to secure the position of the main body 18within the vessel (FIG. 12G).

(xxii) after deployment of the last endovascular staple, removing theendovascular stapler applier 38 from the steerable endovascular guide30.

(xxiii) re-advancing the obturator 32 and then the guide wire into thesteerable endovascular guide.

(xxiv) removing the steerable endovascular guide 30 and the obturator32, leaving the guide wire in position.

3. Deploy the Contralateral Lumen Extension

The instructions for use 58 may next include the deployment of thecontralateral lumen extension 22 of the endovascular graft assembly. Theinstructions may include a series of steps that can be followed to carryout this portion of the procedure. These steps may include:

(i) after flushing with heparinized saline, advancing the contralaterallumen extension delivery system 28 over the guide wire in thecontralateral femoral access site (FIG. 12H).

(ii) using fluoroscopic guidance, aligning the proximal marker 94 on thelumen extension 22 with the insertion depth marker 92 located mediallyon the main body 18.

(iii) holding the lumen extension deliver system 28 stable relative tothe patient, retracting the jacket retraction slide 162 away from thepatient to unsheath the lumen extension 22 (FIG. 12I). The distal end ofthe lumen extension 22 will deploy. The proximal end of the lumenextension 22 will remain collapsed and secured to the delivery system28.

(iv) retracting the proximal stent release slide 156 to release theproximal end of the lumen extension 22 and complete the deployment ofthe lumen extension (FIG. 12J).

(v) rejacketing the lumen extension delivery system by holding thejacket retention slide 162 and slowly retracting the delivery system 28,until the nosecone seals into the proximal end of the jacket 150.

(vi) maintaining forward pressure on the jacket retention slide 162,removing the lumen extension delivery system 28 from the patient,leaving the guide wire and femoral access introducer sheath in place.

4. Complete the Deployment of the Main Body

The instructions for use 58 may next include the completion of thedeployment of the main body 18 of the endovascular graft assembly, whichremains in a secured but partially deployed condition during thedeployment of the contralateral lumen extension 22, as above described.The instructions may include a series of steps that can be followed tocarry out this portion of the procedure. These steps may include:

(i) moving to the ipsilateral femoral access site, where the main bodydelivery system 24 resides.

(ii) releasing the stabilizing arms 106 from the graft by retracting thegraft release slide 116 on the handle of the delivery system away fromthe patient (FIG. 12K).

(iii) releasing the main body ipsilateral lumen from the delivery systemby retracting the ipsilateral release slide 118 on the handle away fromthe patient (FIG. 12L). The main body 18 is now fully released (FIG.12K).

(iv) rejacketing the main body delivery system 24 by holding the jacketretention slide 126 and slowly retract the main body 18 delivery system,until the nosecone seals into the proximal end of the jacket 102.

(vi) maintaining forward pressure on the jacket retention slide 126,remove the main body delivery system 24 from the patient (FIG. 12L),leaving the guide wire and femoral access introducer sheath in place.

5. Deploy the Ipsilateral Lumen Extension

The instructions for use 58 may next include the deployment of theipsilateral lumen extension 20 of the endovascular graft assembly 12.The instructions may include a series of steps that can be followed tocarry out this portion of the procedure. These steps may include:

(i) after flushing with heparinized saline, advancing the ipsilaterallumen extension delivery system 26 over the guide wire in theipsilateral femoral access site (FIG. 12M).

(ii) using fluoroscopic guidance, aligning the proximal marker 92 on thelumen extension 20 with the insertion depth marker 82 located mediallyon the main body 18.

(iii) holding the lumen extension deliver system stable relative to thepatient, retracting the jacket retraction slide 162 away from thepatient to unsheath the lumen extension 20 (FIG. 12N). The distal end ofthe lumen extension 20 will deploy. The proximal end of the lumenextension 20 will remain collapsed and secured to the delivery system26.

(iv) retracting the proximal stent release slide 156 to release theproximal end of the lumen extension 20 and complete the deployment ofthe lumen extension (FIG. 120).

(v) rejacketing the lumen extension delivery system 26 by holding thejacket retention slide 162 and slowly retracting the delivery system 26,until the nosecone seals into the proximal end of the jacket 150.

(vi) maintaining forward pressure on the jacket retention slide 162,removing the lumen extension delivery system 26 from the patient,leaving the guide wire and femoral access introducer sheath in place.

6. Completion of the Procedure

The instructions for use 58 may next include the completion of theprocedure. The instructions may include a series of steps that can befollowed to carry out this portion of the procedure. These steps mayinclude:

(i) performing post-implant aortic angiography to evaluate theimplantation.

(ii) checking for endovascular leaks around the endovascular graftassembly. If a leak is observed, standard endovascular techniques can beused to resolve. Additional staples may be placed, in the mannerdescribed above.

(iii) checking for proper location, blood flow, and patency of theendovascular graft assembly.

(iv) removing the guide wires and femoral access sheaths and close thefemoral arteriotomies according to standard practice (FIG. 12P).

It is to be appreciated that the general steps just described do notnecessarily need to follow the order in which they were described. It isalso to be appreciated that fasteners may be applied to the lumenextensions as well to connect the lumen extensions to the iliacarteries.

It will also be appreciated that the components and/or features of thepreferred embodiments described herein may be used together orseparately, while the depicted methods and devices may be combined ormodified in whole or in part. It is contemplated that the components ofthe guiding device, fastener device, and helical fastener may bealternately oriented relative to each other, for example, offset,bi-axial, etc. Further, it will be understood that the variousembodiments may be used in additional procedures not described herein,such as vascular trauma, arterial dissections, artificial heart valveattachment and attachment of other prosthetic device within the vascularsystem and generally within the body.

The foregoing is considered as illustrative only of the principles ofthe invention. Furthermore, since numerous modifications and changeswill readily occur to those skilled in the art, it is not desired tolimit the invention to the exact construction and operation shown anddescribed. While the preferred embodiment has been described, thedetails may be changed without departing from the invention, which isdefined by the claims.

The desired embodiments of the invention are described above in detailfor the purpose of setting forth a complete disclosure and for the sakeof explanation and clarity. Those skilled in the art will envision othermodifications within the scope and spirit of the present disclosure.

1. A system comprising a guide defining an access path into a vessel orhollow body organ and including a distal region having a terminus, and afastener applier comprising a catheter sized and configured forintroduction along the access path and including an actuated member thatis selectively operable to generate an implantation force to implantwithin tissue at least one fastener, the catheter including indiciavisible to a naked eye to mark when the actuated member rests at adesired distance along the access path short of the terminus of thedistal region and is therefore out of contact with tissue.
 2. A systemaccording to claim 1 wherein the guide includes a passage that definesthe access path, and wherein the catheter is sized and configured forintroduction through the passage, and wherein the indicia marks when theactuated member rests at a desired distance inset within the passagefrom terminus of the distal region.
 3. A system according to claim 2wherein the passage comprises an interior lumen.
 4. A system accordingto claim 1 wherein the access path includes a proximal region having avisible entry to receive the catheter, and wherein the indicia includesa visible marking on the catheter that visibly registers with the entryof the proximal region when the actuated member rests at the desireddistance short of the terminus of the distal region.
 5. A systemaccording to claim 1 wherein the distal region is deflectable.
 6. Asystem according to claim 1 wherein the at least one fastener comprisesa tissue-piercing fastener.
 7. A system according to claim 6 wherein thetissue-piercing fastener comprises a helical fastener.
 8. A systemcomprising a guide defining an access path into a vessel or hollow bodyorgan and including a distal region having a terminus, a fastenerapplier comprising a catheter sized and configured for introductionalong the access path and including an actuated member that isselectively operable to generate an implantation force to implant withintissue at least one fastener, the catheter including indicia visible toa naked eye to mark when the actuated member rests at a desired distancealong the access path short of the terminus of the distal region and outof contact with tissue, and instructions for using the guide andfastener applier comprising introducing the guide to a location at atarget site within a vessel or hollow body organ where a diseased ordamaged section exists, establishing the access path to a desiredfastening site at the target site by manipulating the guide to orientthe terminus with respect to the desired fastening site, introducing theactuated member along the access path toward the terminus; and viewingthe indicia with a naked eye to detect when the actuated member rests ata desired distance along the access path short of the terminus of thedistal region.
 9. A method comprising (i) providing a system as definedin claim 1 or 8 (ii) introducing the guide to a location at a targetsite within a vessel or hollow body organ where a diseased or damagedsection exists; (iii) establishing the access path to a desiredfastening site at the target site by manipulating the guide to orientthe terminus with respect to the desired fastening site; (iv)introducing the actuated member along the access path toward theterminus; and (v) viewing the indicia with a naked eye to detect whenthe actuated member rests at a desired distance along the access pathshort of the terminus of the distal region.
 10. A method according toclaim 9 (vi) after (v), advancing the actuated member to the terminus ofthe distal region, and (vii) operating the actuated member to generatean implantation force to implant the into tissue at the desiredfastening site.
 11. A method according to claim 9 wherein (iii) includesrotating the guide and/or deflecting the distal region.
 12. An apparatuscomprising a fastener applier comprising a catheter sized and configuredfor introduction along an access path into a vessel or hollow body organand. including an actuated member that is selectively operable in afirst direction to load at least one fastener and in a second directionto generate an implantation force to implant the fastener within tissue,an electrically powered drive member coupled to the driven member, and acontroller coupled to the drive motor including a LOAD state includingmeans operable in response to an input command for delivering electricalcurrent to the drive member to drive the driven member in a firstdirection to load a fastener onto the driven member, means for sensingelectrical current delivered to the drive member while loading thefastener onto the driven member, and means for terminating delivery ofelectrical current to the driven member when a prescribed amount ofcurrent is delivered to the drive member, thereby terminating the LOADstate.
 13. An apparatus according to claim 12 wherein the controllerincludes an UNWIND state including means, operative after termination ofthe LOAD state, for delivering electrical current to the drive member todrive the driven member in the second direction, means for sensing aperiod of operation of the driven member in the second directionsufficient to reduce torque windup on the driven member during the LOADstate, means for terminating delivery of electrical current to thedriven member after the period of operation, thereby terminating theUNWIND state.
 14. An apparatus according to claim 13 wherein thecontroller includes a READY TO APPLY state including means, operativeafter termination of the UNWIND state, to prompt a prescribed implantfastener input command.
 15. An apparatus according to claim 14 whereinthe READY TO APPLY state includes means operable in response to theprescribed implant fastener input command for delivering electricalcurrent to the drive member to drive the driven member in the seconddirection, means for sensing a partial period of operation of the drivenmember in the second direction less than a full period of operationsufficient to fully implant the fastener in tissue, means forterminating delivery of electrical current to the driven member afterthe partial period of operation, and means for prompting entry of eithera continue implantation input command or a terminate implantationimplant command.
 16. An apparatus according to claim 15 wherein theREADY TO APPLY STATE includes means, operative in response to thecontinue implantation command, for delivering electrical current to thedrive member to drive the driven member in the second directionsufficient to fully implant the fastener in tissue.
 17. An apparatusaccording to claim 15 or 16 wherein the READY TO APPLY STATE includesmeans, operative in response to the terminate implantation command, fordelivering electrical current to the drive member to drive the drivenmember in the first direction sufficient to withdraw the fastener fromtissue.
 18. A method comprising (i) providing the apparatus as definedin claim 12, (ii) operating the fastener applier in the LOAD state toload a fastener onto the driven member, and (iii) after (ii),introducing the fastener applier to a location at a target site within avessel or hollow body organ where a diseased or damaged section exists.19. A method comprising (i) providing the apparatus as defined in claim13, (ii) operating the fastener applier in the LOAD and UNWIND states toload a fastener onto the driven member, and (iii) after (ii),introducing the fastener applier to a location at a target site within avessel or hollow body organ where a diseased or damaged section exists.20. A seal assembly a first seal component with at least one guide tubeformed therein, a second seal component with at least one guide tubeformed therein, the second seal component registering with the firstseal component with at least one guide tube in the second componentcoaxially aligned with at least one guide tube in the first component, aseptum sandwiched between the first and second seal components, theseptum accommodating passage of a control filament from one thecoaxially aligned guide tubes, through the septum, to the other one ofthe coaxially aligned guide tubes, thereby providing a fluid seal forthe control filament.
 21. An assembly according to claim 20 wherein atleast one of the first and second seal components is substantiallyrigid.
 22. An assembly according to claim 21 wherein the septumcomprises a soft material.
 23. An assembly according to claim 21 whereinthe septum comprises silicone rubber.
 24. An assembly according to claim21 wherein the septum comprises a gasket.
 25. An assembly according toclaim 20 wherein both of the first and second seal components aresubstantially rigid.
 26. An assembly according to claim 25 wherein theseptum comprises a soft material.
 27. An assembly according to claim 25wherein the septum comprises silicone rubber.
 28. An assembly accordingto claim 25 wherein the septum comprises a gasket.
 29. An apparatuscomprising a catheter assembly including an operative element that, inuse, is exposed to a body fluid, a control element, a control filamentcoupled at one end to the control element and to an opposite end to theoperative element, and a seal assembly between the control element andthe operative element through which the control filament passes toprevent contact between the body fluid and the control element, the sealassembly comprising a first seal component with at least one guide tubeformed therein, a second seal component with at least one guide tubeformed therein, the second seal component registering with the firstseal component with at least one guide tube in the second componentcoaxially aligned with at least one guide tube in the first component,and a septum sandwiched between the first and second seal components,the septum accommodating passage of the control filament from one thecoaxially aligned guide tubes, through the septum, to the other one ofthe coaxially aligned guide tubes, thereby providing a fluid seal forthe control filament.